Multidrug Resistance in Newly Diagnosed TB Patient

NCT ID: NCT06700577

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-11-30

Brief Summary

Tuberculosis (TB) is one of the major public health threats, competing with the human immunodeficiency virus (HIV) as the cause of death due to infectious diseases worldwide.

Multi drug-resistant Mycobacterium tuberculosis (MDR-TB) is one of the leading causes of death in the world.

The resource constraints make it difficult to diagnose and monitor the cases of MDR-TB.

GeneXpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe MDR Multidrug-resistant tuberculosis (MDR-TB), caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates, the median prevalence of MDR-TB has been 1.1% in newly diagnosed patients. The proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-TB treatment.

XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines MDR tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin The main causes of the spread of resistant TB are weak medical Systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. Although patients harboring MDR and XDR strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

Detailed Description

To detect the prevalence of MDR T.B. using xpert MTB/RIF ultra and XDR assay in newly diagnosed cases

Conditions

Tuberculosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Gene expert

Gene expert and XDR to detect multidrug resistance between tb patient

Intervention Type: DIAGNOSTIC_TEST

Ultra xpert and xdr xpert

Detect resistance between tyberculous patient

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• newly diagnosed tuberculosis patient
• Diagnosed by direct smear for sputum or body fluid

Exclusion Criteria

• previously treated patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fatma nashat esmail zyada

Pulomongist , principale investigator , Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Nashat esmail zyada Resident doctor

Role: CONTACT

nashatfatma209@gmail.com

0201033865906

References

Seung KJ, Keshavjee S, Rich ML. Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. Cold Spring Harb Perspect Med. 2015 Apr 27;5(9):a017863. doi: 10.1101/cshperspect.a017863.

Reference Type: BACKGROUND

PMID: 25918181 (View on PubMed)

Other Identifiers

Gene expert and Tuberculosis

Identifier Type: -

Identifier Source: org_study_id